Diaglucide Side Effects

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Answer the side-effect intent for diaglucide without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Diaglucide?

Diaglucide contains the active ingredient Gliclazide.

• Active ingredient — Gliclazide
• Registration number — A42/21.2/0249; A48/21.2/1184; A53/21.2/0083
• Registration holder — Pharma Dynamics (Pty) Ltd

It is approved for:

• DYNACAZ MR contains gliclazide and belongs to a group of medicines called sulphonylurea antidiabetic medicine
• It is used to treat a certain type of diabetes mellitus called type 2 diabetes in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level
• When you have type 2 diabetes, the amount of insulin your pancreas produces may not be enough or your body may not be using it properly and you may still need more
• DYNACAZ MR works by causing your pancreas to release more insulin into the blood stream

Common side effects of Diaglucide

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• headache, dizziness, drowsiness
• constipation, diarrhoea, stomach pain or discomfort, stomach spasms, decreased or increased appetite, heartburn, bloating, flatulence (gas), weight gain, nausea, vomiting, changes in sense of taste (metallic taste)

Less frequent side effects

• decrease in the number of cells in the blood, resulting in abnormal blood test results including anaemia
• low sodium levels in the blood, anorexia
• blurred vision, worsening eyesight
• abnormal liver function (clay coloured stool, dark urine, itching, loss of appetite, yellow eyes or skin). The following side effects have been reported but the frequency for them to occur is not known:
• hives, itching, inflammation of the skin, rash, redness of the skin, sensitivity to light, dry skin, blistering or peeling of the skin, thinning of the skin, pale skin, unusual bruising

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are hypersensitive (allergic) to gliclazide, sulphonylureas (medicine for diabetes), sulphonamides (a type of antibiotic), or to any of the ingredients of DYNACAZ MR
• if you have type 1 diabetes mellitus (type 1 diabetes patients cannot produce or release insulin from their pancreas)
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic keto-acidosis), a diabetic pre-coma or coma
• if you have acid (acidosis) or ketones (diabetic ketoacidosis – a life-threatening problem that occurs when the body cannot use sugar (glucose) as a fuel source because there is no insulin or not enough insulin in your blood)
• if you have severe burns or injuries, a severe infection or had a major surgery
• if you have a liver disease
• if you have a kidney disease
• if you are taking a medicine to treat fungal infections called miconazole
• if you are a child, as the safety of DYNACAZ MR has not been studied in children
• if you are pregnant or breastfeeding your baby

Use with care, and tell your doctor, if

• if you are a patient, especially elderly or unable to cooperate
• if you do not eat meals at regular intervals or skip meals altogether
• if you are fasting
• if you are malnourished
• if you change your diet
• if you increase your physical activity and carbohydrate intake does not match this increase
• if you drink a significant amount of alcohol, especially when skipping meals
• if you have any severe abnormal condition of the blood vessels (arteries and veins), including severe heart disease
• if you are taking or have recently stopped taking high doses of corticosteroids (used for pain and inflammation)
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex)
• if your kidney function or liver function is severely decreased
• if you take other medicines or natural remedies at the same time
• if you have taken an overdose of DYNACAZ MR. If you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness. The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris). If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious. In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, for instance glucose tablets, sugar cubes, sweet juice, sweetened tea. Remember that artificial sweeteners are not effective. You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur. In order to avoid gastrointestinal side effects, you should take your tablets with breakfast. Should you experience side effects affecting the liver, your doctor may change your medicine. If you have a family history of or know you have the hereditary condition glucose-6- phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking DYNACAZ MR. Symptoms of low blood sugar may be absent, less obvious, or develop very slowly, or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta blockers). It is important that you learn which symptoms of low blood sugar you usually have, so that you can treat it quickly. You must also educate your family members about the symptoms of hypoglycaemia and how to treat them. Symptoms of high blood sugar (hyperglycaemia) may occur when: gliclazide has not yet sufficiently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor, if you take St John’s wort (Hypericum perforatum) preparations, or in special stress situations. If you are in stress situations (accidents, surgical operations, fever etc.), your doctor may temporarily switch you to insulin therapy. Symptoms of high blood sugar may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance. If these symptoms occur, you must contact your healthcare provider or pharmacist. The effects of DYNACAZ MR may reduce over long periods of time and your doctor may increase your dose and request you increase the frequency of monitoring of your sugar levels. Blood glucose disturbance (low blood sugar and high blood sugar) can occur when DYNACAZ MR is prescribed at the same time as medicines belonging to a class of antibiotics called fluoroquinolones, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose. There is a potential for the occurrence of serious skin conditions to develop (toxic dermal necrolysis and allergic vasculitis). Symptoms include a painful, red area that spreads quickly, skin peeling without blistering, raw areas of skin, discomfort, fever, purple-coloured spots and patches on the skin, blisters, hives, open sores). Your doctor may request tests to monitor your condition before or during treatment. The safety and efficacy of DYNACAZ MR in children has not been established

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine
• You should not take this medicine if you are pregnant or breastfeeding your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• a medicine containing miconazole (used to treat fungal infections). The following medicines or substances may cause your blood sugar levels to fall even lower than normal when taken together with DYNACAZ MR and are therefore not recommended for use:
• phenylbutazone (used to treat pain and inflammation)
• alcohol increases the risk of hypoglycaemia (low blood sugar) and coma. Alcohol and medicines containing alcohol should be avoided. The blood sugar lowering effect of DYNACAZ MR may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken:
• allopurinol, probenecid, sulphinpyrazone (anti-gout medicine)
• anabolic steroids (a steroid hormone which promotes muscle growth) and androgens (male sex hormone)
• certain medicines used to treat high blood pressure and heart disease called ACE inhibitors (captopril, enalapril, quinidine, quinine and clonidine), and antidysrhythmics (disopyramide)
• medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril, or enalapril)
• antibiotics (chloramphenicol, sulphonamides, quinolones, tetracyclines, clarithromycin)
• certain antidepressants such as fluoxetine (monoamine-oxidase inhibitors)
• certain medicines used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole, fluconazole
• the appetite suppressant fenfluramine
• ranitidine and cimetidine (medicines used to treat heartburn)
• fibrates (such as clofibrate) used to treat high cholesterol
• insulin and other oral antidiabetic medicines (such as acarbose, metformin, thiazolidinediones, GLP-1 receptor inhibitors)
• certain medicines used to treat pain and inflammation (NSAIDs and salicylates)
• beta-blockers (used to control heart rhythm, treat angina, and reduce high blood pressure) may increase the chance that high or low blood sugar can occur. Also, they can hide the symptoms of low blood sugar. The blood glucose lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken with DYNACAZ MR:
• danazol used to treat breast disorders, heavy menstrual bleeding and endometriosis is not recommended for use with DYNACAZ MR. If it cannot be avoided, regular urine and blood glucose monitoring must be done. Your dose of DYNACAZ MR may need to be adjusted
• epinephrine (adrenaline), asthma medicines (salbutamol, terbutaline), cough and cold medicines containing ephedrine and pseudoephedrine
• corticosteroids (cortisone-like medicines used to treat inflammation)
• calcium channel blockers, clonidine, diazoxide (cardiovascular medicines used to treat heart problems)
• chlorpromazine (tranquiliser or sedative also used for nausea or vomiting)
• lithium (used to treat certain types of depression)
• thiazide diuretics (water tablets)
• anti-epileptic medication such as phenytoin
• glucagon (a hormone that assists with the breakdown of glycogen to glucose)
• female hormones oestrogen and progesterone
• antibacterial medicines rifampicin and isoniazid
• thyroid hormones
• glucocorticoids (used to assist the body to break down carbohydrates, proteins and fats)
• medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline). Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time than DYNACAZ MR, especially in elderly patients. DYNACAZ MR may increase the effects of anticoagulants (medicines which reduce blood clotting e.g. warfarin). Your dose of anticoagulant may need to be adjusted. DYNACAZ MR with food and drink DYNACAZ MR must be taken with food. The tablet must be swallowed whole with half a glass of water and should be taken immediately before a substantial breakfast or the first main meal of the day. You should not miss a meal after you have taken the tablets. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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